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Abstract:

Described are ethanol-free foamable microemulsions for topical
application, and method of making them. The propellants used in the
compositions may be environmentally-friendly hydrofluoroalkanes. The foam
compositions may also comprise one or more of a variety of active
ingredients, including anti-inflammatory agents, anesthetics, and
keratolytic agents.

Claims:

1. A composition, consisting essentially ofan aqueous phase, from about
15% to about 40% by weight;a co-surfactant, from about 10% to about 20%
by weight;an active agent, from about 0.01% to about 10% by weight;a
surfactant, from about 15% to about 40% by weight;a propellant, from
about 5% to about 15% by weight, wherein the propellant is a
hydrofluoroalkane;a preservative, from about 0.005% to about 3.0% by
weight; andan oil phase, from about 10% to about 35% by weight.

3. The composition of claim 1, wherein the oil phase is isopropyl
myristate.

4. A composition consisting essentially ofwater, from about 15% to about
40% by weight;a co-surfactant, from about 10% to about 20% by weight;an
active agent, from about 0.01% to about 10% by weight;a surfactant, from
about 15% to about 40% by weight;a propellant, from about 5% to about 15%
by weight, wherein the propellant is a hydrofluoroalkane;a preservative,
from about 0.005% to about 3.0% by weight; andisopropyl myristate, from
about 10% to about 35% by weight.

5. The composition of claim 4, wherein the composition does not comprise
ethanol.

6. The composition of claim 4, wherein the co-surfactant is propylene
glycol.

7. The composition of claim 4, wherein the active agent is selected from
the group consisting of an antibiotic agent, an anti-inflammatory agent,
an anesthetic, an antimicrobial agent, and a keratolytic agent.

8. The composition of claim 4, wherein the active agent is an anesthetic.

9. The composition of claim 8, wherein the anesthetic is lidocaine.

10. The composition of claim 4, wherein the surfactant is a polysorbate.

11. The composition of claim 4, wherein the surfactant is polysorbate 80.

12. The composition of claim 4, wherein the hydrofluoroalkane is
1,1,1,2-tetrafluoroethane.

13. The composition of claim 4, wherein the preservative is a quaternary
ammonium compound, an alcoholic agent, or a combination of both.

14. The composition of claim 4, wherein the preservative is a combination
of benzalkonium chloride and benzyl alcohol.

15. A composition consisting essentially ofwater, in about 20% by weight;a
co-surfactant, in about 14% by weight, wherein the co-surfactant is
propylene glycol;an active agent, in about 4.0% by weight, wherein the
active agent is lidocaine;a surfactant, in about 39% by weight, wherein
the surfactant is polysorbate 80;a propellant, in about 6% by weight,
wherein the propellant is 1,1,1,2-tetrafluoroethane;a preservative,
wherein the preservative is benzalkonium chloride, in about 0.04% by
weight, and benzyl alcohol, in about 1.9% by weight; andisopropyl
myristate, in about 15% by weight.

16. A method of treating the skin of a subject, comprising the step
ofapplying to the skin of a subject in need thereof a composition of any
one of claims 1-15.

17. The method of claim 16, wherein the subject is suffering from a
dermatological condition.

18. The method of claim 16, wherein the skin of the subject is to be
anesthetized.

Description:

RELATED APPLICATIONS

[0001]This application claims the benefit of priority to U.S. Provisional
Patent Application Ser. No. 61/028,586, filed Feb. 14, 2008; the contents
of which are hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

[0002]The present invention is in the field of foamable microemulsion
compositions for topical administration.

BACKGROUND OF THE INVENTION

[0003]Microemulsions are thermodynamically-stable, optically-clear
emulsions having submicron-sized droplets suspended in a continuous
phase. These emulsions form spontaneously and typically consist of an
aqueous phase, an organic phase, and a surfactant/co-surfactant
component.

[0004]Previous data suggest that ethanol is required to maintain stable
oil-in-water microemulsions. However, topical application of ethanol has
a drying effect on the skin. Additionally, ethanol and compositions
containing ethanol are extremely flammable. For these reasons,
ethanol-containing microemulsions for topical application have seen
limited commercial use.

SUMMARY OF THE INVENTION

[0005]In certain embodiments, the present invention relates to a
composition comprising: an aqueous phase, from about 15% to about 40% by
weight; a co-surfactant, from about 10% to about 20% by weight; an active
agent, from about 0.01% to about 10% by weight; a surfactant, from about
15% to about 40% by weight; a propellant, from about 5% to about 15% by
weight, wherein the propellant is a hydrofluoroalkane; and an oil phase,
from about 10% to about 35% by weight. In certain embodiments, the
present invention relates to a composition comprising: water, from about
15% to about 30% by weight; a co-surfactant, from about 10% to about 20%
by weight; an active agent, from about 0.01% to about 10% by weight; a
surfactant, from about 30% to about 40% by weight; a propellant, from
about 5% to about 15% by weight, wherein the propellant is a
hydrofluoroalkane; and isopropyl myristate, from about 10% to about 20%
by weight. In certain embodiments, the present invention relates to any
one of the above-mentioned compositions, wherein the composition does not
comprise ethanol. In certain embodiments, the compositions of the present
invention produce foam upon actuation by an aerosol container.

[0006]In certain embodiments, the invention relates to a method of
preparation, comprising first formulating an active agent-containing
microemulsion concentrate, then placing the concentrate into an aerosol
container and, lastly, mixing the concentrate and pressurizing the
container with a propellant to result in a stable, optically-clear
propellant-containing microemulsion.

[0015]One aspect of the invention relates to a composition comprising a
stable, optically-clear microemulsion. In certain embodiments, the
invention relates to an above-mentioned composition, wherein the
microemulsion comprises water, co-surfactant, surfactant, emulsifier, and
preservative. In certain embodiments, the invention relates to any one of
the above-mentioned compositions, wherein the microemulsion further
comprises an active agent. In certain embodiments, the invention relates
to any one of the above-mentioned compositions, wherein the microemulsion
does not comprise ethanol.

[0016]In one embodiment, one or more other solvents can substitute for
ethanol in the formulation of microemulsions. In one embodiment,
propylene glycol is used in the microemulsion instead of ethanol. When
mixed in certain ratios, ternary systems of water, isopropyl myristate,
and polysorbate 80:propylene glycol (2.5:1) allow a clear microemulsion
to be formed (see, e.g., FIG. 2). Surprisingly, these systems exhibit
phase behavior similar to systems containing ethanol (compare FIG. 2 to
FIG. 1). Microemulsions formulated using the ternary system of water,
isopropyl myristate, and polysorbate 80:propylene glycol (2.5:1) resulted
in optically-clear, thermodynamically-stable microemulsions. These
microemulsions maintained the active ingredient in solution without
disrupting microemulsion structure.

[0017]In certain embodiments, the active agent-containing microemulsion,
upon mixing with a propellant in a pressurized container, remains a
single-phase, optically-clear microemulsion. Upon actuation from an
aerosol container, microemulsions of the present invention produce foam.

[0018]Exemplary identities of various constituents of the compositions of
the present invention are described below.

1. Propellants

[0019]In certain embodiments, the propellant is a HFA or a mixture of one
or more hydrofluorocarbons. Suitable hydrofluorocarbons include
1,1,1,2-tetrafluoroethane (HFA 134a); 1,1,1,2,3,3,3-heptafluoropropane
(HFA 227); and mixtures and admixtures of these and other HFAs that are
currently approved or may become approved for medical use are suitable.
The concentration of the HFA propellant is from about 2% to about 30% by
weight of the concentrate. Hydrocarbon as well as CFC propellants can
also be used in the present invention.

2. Active Agents

[0020]The active agent may be any material that has a desired effect when
applied topically to a mammal, particularly a human. Suitable classes of
active agents include, but are not limited to, antibiotic agents,
antimicrobial agents, anti-acne agents, antibacterial agents, antifungal
agents, antiviral agents, steroidal anti-inflammatory agents,
non-steroidal anti-inflammatory agents, anesthetic agents,
antipruriginous agents, antiprotozoal agents, anti-oxidants,
antihistamines, vitamins, and hormones. Mixtures of any of these active
agents may also be employed. Additionally, dermatologically-acceptable
salts and esters of any of these agents may be employed.

[0021]2.1 Antibiotics

[0022]Representative antibiotics include, without limitation, benzoyl
peroxide, octopirox, erythromycin, zinc, tetracyclin, triclosan, azelaic
acid and its derivatives, phenoxy ethanol and phenoxy propanol, ethyl
acetate, clindamycin and meclocycline; sebostats such as flavinoids;
alpha and beta hydroxy acids; and bile salts such as scymnol sulfate and
its derivatives, deoxycholate and cholate. The antibiotic can be an
antifungal agent. Suitable antifungal agents include, but are not limited
to, clotrimazole, econazole, ketoconazole, itraconazole, miconazole,
oxiconazole, sulconazole, butenafine, naftifine, terbinafine, undecylinic
acid, tolnaftate, and nystatin. Mixtures of these antibiotic agents may
also be employed. Additionally, dermatologically-acceptable salts and
esters of any of these agents may be employed.

[0028]Suitable anesthetics include the aminoacylanilide compounds such as
lidocaine, prilocalne, bupivacaine, levo-bupivacaine, ropivacaine,
mepivacaine and related local anesthetic compounds having various
substituents on the ring system or amine nitrogen; the aminoalkyl
benzoate compounds, such as procaine, chloroprocaine, propoxycaine,
hexylcaine, tetracaine, cyclomethycaine, benoxinate, butacaine,
proparacaine, butamben, and related local anesthetic compounds; cocaine
and related local anesthetic compounds; amino carbonate compounds such as
diperodon and related local anesthetic compounds; N-phenylamidine
compounds such as phenacaine and related anesthetic compounds;
N-aminoalkyl amide compounds such as dibucaine and related local
anesthetic compounds; aminoketone compounds such as falicaine, dyclonine
and related local anesthetic compounds; and amino ether compounds such as
pramoxine, dimethisoquien, and related local anesthetic compounds; and
para-amino benzoic acid esters such as benzocaine. Other suitable local
anesthetics include ketocaine, dibucaine, amethocaine, propanacaine, and
propipocaine.

[0040]Many of these surfactants may also serve as emulsifiers in
formulations of the present invention.

5. Co-surfactants

[0041]A co-surfactant is a surface-active agent that acts in addition to
the surfactant by further lowering the interfacial energy, but that would
not effectively function alone as a surfactant. For example, short-chain
alcohols are found to concentrate in the surfactant layer of aggregates,
replacing surfactant molecules and leading to a decrease in the
aggregation number, and an increase in the number of aggregates. These
molecules directly influence the properties of the aggregates.

[0042]Suitable co-surfactants of the present invention include, but are
not limited to, ethanol, propylene glycol, 1-butanol, 1-decanol, and
combinations of any of them. Furthermore, medium chain alcohols, oleic
esters of polyglycerol, polyglyceryl-3-oleate (Plurol Oleique®),
polyglyceryl isostearate, or polyglyceryl-6 isostearate (Plurol
Isostearique®) may also be employed separately or in combination with
any other co-surfactant.

6. Aqueous Phase

[0043]In certain embodiments, a composition of the present invention is an
oil-in-water emulsion. Suitable components for use in formulating the
aqueous phase of such an oil-in-water emulsion include water, aqueous
buffers with various pH levels (e.g., pH about 2, pH about 3, pH about 4,
pH about 5, pH about 6, pH about 7, pH about 8, pH about 9, pH about 10,
pH about 11, or pH about 12), and water-miscible solvents, such as
glycols, glycerol, liquid polyols, and dimethyl sulfoxide. One or more
aqueous component may be present.

[0047]Additional constituents suitable for incorporation into the
microemulsions of the present invention include, but are not limited to:
protectives, adsorbents, demulcents, emollients, moisturizers, buffering
agents, solubilizing agents, and skin-penetration agents.

[0048]Often, one constituent of a composition may accomplish several
functions. In certain embodiments, the present invention relates to
constituents that may act as a lubricant, an emollient, or a
skin-penetrating agent. In certain embodiments, the multi-functional
constituent is isostearylic isostearate, isopropyl isostearate, isopropyl
palmitate, or isopropyl myristate.

[0078]a propellant, from about 5% to about 15% by weight, wherein the
propellant is a hydrofluoroalkane; and

[0079]isopropyl myristate, from about 10% to about 20% by weight.

[0080]In certain embodiments, the present invention relates to a
composition consisting essentially of

[0081]water, from about 15% to about 30% by weight;

[0082]a co-surfactant, from about 10% to about 20% by weight;

[0083]an active agent, from about 0.01% to about 10% by weight;

[0084]a surfactant, from about 30% to about 40% by weight;

[0085]a propellant, from about 5% to about 15% by weight, wherein the
propellant is a hydrofluoroalkane; and

[0086]isopropyl myristate, from about 10% to about 20% by weight.

[0087]In certain embodiments, the present invention relates to a
composition consisting of water, from about 15% to about 30% by weight;

[0088]a co-surfactant, from about 10% to about 20% by weight;

[0089]an active agent, from about 0.01% to about 10% by weight;

[0090]a surfactant, from about 30% to about 40% by weight;

[0091]a propellant, from about 5% to about 15% by weight, wherein the
propellant is a hydrofluoroalkane; and

[0092]isopropyl myristate, from about 10% to about 20% by weight.

[0093]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the composition does not
comprise ethanol.

[0094]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein water is present in a quantity
from about 17% to about 25% by weight. In certain embodiments, the
present invention relates to any one of the above-mentioned compositions,
wherein water is present in a quantity from about 18% to about 24% by
weight. In certain embodiments, the present invention relates to any one
of the above-mentioned compositions, wherein water is present in about
18%, about 19%, about 20%, about 21%, about 22%, about 23%, or about 24%
by weight. In certain embodiments, the present invention relates to any
one of the above-mentioned compositions, wherein water is present in
about 18% by weight. In certain embodiments, the present invention
relates to any one of the above-mentioned compositions, wherein water is
present in about 20% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
water is present in about 24% by weight.

[0095]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the co-surfactant is ethylene
glycol, propylene glycol, or glycerol.

[0096]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the co-surfactant is propylene
glycol.

[0097]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the co-surfactant is present in
a quantity from about 11% to about 18% by weight. In certain embodiments,
the present invention relates to any one of the above-mentioned
compositions, wherein the co-surfactant is present in a quantity from
about 12% to about 17% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
the co-surfactant is present in about 13%, about 14%, about 15%, or about
16% by weight. In certain embodiments, the present invention relates to
any one of the above-mentioned compositions, wherein the co-surfactant is
present in about 13% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
the co-surfactant is present in about 14% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the co-surfactant is present in
about 15% by weight. In certain embodiments, the present invention
relates to any one of the above-mentioned compositions, wherein the
co-surfactant is present in about 16% by weight.

[0098]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the active agent is selected
from the group consisting of an antibiotic agent, an anti-inflammatory
agent, an anesthetic, an antimicrobial agent, and a keratolytic agent.

[0099]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the active agent is present in
a quantity from about 0.05% to about 8.0% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the active agent is present in a
quantity from about 0.06% to about 7% by weight. In certain embodiments,
the present invention relates to any one of the above-mentioned
compositions, wherein the active agent is present in about 0.06%, about
0.07%, about 0.08%, about 0.1%, about 0.2%, about 0.3%, about 0.4%, about
0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1.0%, about
1.5%, about 2.0%, about 2.5%, about 3.0%, about 3.5%, about 4.0%, about
4.5%, about 5.0%, about 5.5%, about 6.0%, about 6.5%, or about 7.0% by
weight.

[0100]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the active agent is an
anesthetic.

[0101]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the anesthetic is lidocaine.

[0102]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the anesthetic is present in a
quantity from about 1% to about 6% by weight. In certain embodiments, the
present invention relates to any one of the above-mentioned compositions,
wherein the anesthetic is present in a quantity from about 2% to about 5%
by weight. In certain embodiments, the present invention relates to any
one of the above-mentioned compositions, wherein the anesthetic is
present in about 2.0%, about 2.5%, about 3.0%, about 3.5%, about 4.0%,
about 4.5%, or about 5.0% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
the anesthetic is present in about 3.5% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the anesthetic is present in about
4.0% by weight. In certain embodiments, the present invention relates to
any one of the above-mentioned compositions, wherein the anesthetic is
present in about 4.5% by weight.

[0103]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the active agent is an
anti-inflammatory agent.

[0104]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the anti-inflammatory agent is
a non-steroidal anti-inflammatory agent or a steroidal anti-inflammatory
agent.

[0105]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the steroidal anti-inflammatory
agent is triamcinolone acetonide or betamethasone dipropionate.

[0106]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the steroidal anti-inflammatory
agent is triamcinolone acetonide.

[0107]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the steroidal anti-inflammatory
agent is betamethasone dipropionate.

[0108]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the anti-inflammatory agent is
present in a quantity from about 0.05% to about 1.5% by weight. In
certain embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the anti-inflammatory agent is
present in a quantity from about 0.06% to about 1.0% by weight. In
certain embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the anti-inflammatory agent is
present in about 0.06%, about 0.07%, about 0.08%, about 0.09%, about
0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about
0.7%, about 0.8%, about 0.9%, or about 1.0% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the anti-inflammatory agent is
present in about 0.08% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
the anti-inflammatory agent is present in about 0.09% by weight. In
certain embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the anti-inflammatory agent is
present in about 0.1% by weight.

[0109]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the active agent is a
keratolytic agent.

[0110]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the keratolytic agent is
salicylic acid.

[0111]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the keratolytic agent is
present in a quantity from about 2.0% to about 8.0% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the keratolytic agent is present in
a quantity from about 3.0% to about 7.0% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the keratolytic agent is present in
about 3.0%, about 3.5%, about 4.0%, about 4.5%, about 5.0%, about 5.5%,
about 6.0%, about 6.5%, or about 7.0% by weight. In certain embodiments,
the present invention relates to any one of the above-mentioned
compositions, wherein the keratolytic agent is present in about 5.0% by
weight. In certain embodiments, the present invention relates to any one
of the above-mentioned compositions, wherein the keratolytic agent is
present in about 5.5% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
the keratolytic agent is present in about 6.0% by weight.

[0112]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the active agent is a
skin-soothing agent.

[0113]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the skin-soothing agent is aloe
vera.

[0114]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the skin-soothing agent is
present in a quantity from about 0.05% to about 2.0% by weight. In
certain embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the skin-soothing agent is present
in a quantity from about 0.08% to about 1.5% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the skin-soothing agent is present
in about 0.08%, about 0.09%, about 0.1%, about 0.2%, about 0.3%, about
0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about
1.0%, about 1.1%, about 1.2%, about 1.3%, about 1.4%, or about 1.5% by
weight. In certain embodiments, the present invention relates to any one
of the above-mentioned compositions, wherein the skin-soothing agent is
present in about 0.08% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
the skin-soothing agent is present in about 0.09% by weight.

[0115]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the skin-soothing agent is
present in about 0.1% by weight.

[0116]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, further comprising a second active
agent.

[0118]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the surfactant is a
polysorbate.

[0119]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the surfactant is polysorbate
80.

[0120]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the surfactant is present in a
quantity from about 32% to about 39% by weight. In certain embodiments,
the present invention relates to any one of the above-mentioned
compositions, wherein the surfactant is present in a quantity from about
33% to about 39% by weight. In certain embodiments, the present invention
relates to any one of the above-mentioned compositions, wherein the
surfactant is present in about 33%, about 34%, about 35%, about 36%,
about 37%, about 38%, or about 39% by weight. In certain embodiments, the
present invention relates to any one of the above-mentioned compositions,
wherein the surfactant is present in about 34% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the surfactant is present in about
36% by weight. In certain embodiments, the present invention relates to
any one of the above-mentioned compositions, wherein the surfactant is
present in about 38% by weight.

[0121]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the hydrofluoroalkane is
1,1,1,2,3,3,3-heptafluoropropane, 1,1,1,2-tetrafluoroethane, or a mixture
thereof.

[0122]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the hydrofluoroalkane is
1,1,1,2-tetrafluoroethane.

[0123]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the propellant is present in a
quantity from about 5% to about 13% by weight. In certain embodiments,
the present invention relates to any one of the above-mentioned
compositions, wherein the propellant is present in a quantity from about
6% to about 13% by weight. In certain embodiments, the present invention
relates to any one of the above-mentioned compositions, wherein the
propellant is present in about 6%, about 7%, about 8%, about 9%, about
10%, about 11%, about 12%, or about 13% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the propellant is present in about
6% by weight. In certain embodiments, the present invention relates to
any one of the above-mentioned compositions, wherein the propellant is
present in about 12% by weight.

[0124]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, further comprising a preservative.

[0126]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the preservative is a
quaternary ammonium compound, an alcoholic agent, or a combination of
both.

[0127]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the preservative is
benzalkonium chloride.

[0128]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the preservative is benzyl
alcohol.

[0129]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the preservative is a
combination of benzalkonium chloride and benzyl alcohol.

[0130]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the preservative is present in
a quantity from about 0.005% to about 3% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the preservative is present in a
quantity from about 0.01% to about 2.5% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the preservative is present in
about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about
0.06%, about 0.07%, about 0.08%, about 1.0%, about 1.5%, about 2.0%, or
about 2.5% by weight.

[0131]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the benzalkonium chloride is
present in a quantity from about 0.005% to about 0.1% by weight. In
certain embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the benzalkonium chloride is
present in a quantity from about 0.008% to about 0.08% by weight. In
certain embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the benzalkonium chloride is
present in about 0.008%, about 0.009%, about 0.01%, about 0.02%, about
0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, or about 0.08%
by weight. In certain embodiments, the present invention relates to any
one of the above-mentioned compositions, wherein the benzalkonium
chloride is present in about 0.01% by weight. In certain embodiments, the
present invention relates to any one of the above-mentioned compositions,
wherein the benzalkonium chloride is present in about 0.02% by weight. In
certain embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the benzalkonium chloride is
present in about 0.04% by weight.

[0132]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the benzyl alcohol is present
in a quantity from about 0.8% to about 3.0% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the benzyl alcohol is present in a
quantity from about 1.2% to about 2.5% by weight. In certain embodiments,
the present invention relates to any one of the above-mentioned
compositions, wherein the benzyl alcohol is present in about 1.2%, about
1.3%, about 1.4%, about 1.5%, about 1.6%, about 1.7%, about 1.8%, about
1.9%, about 2.0%, about 2.1%, about 2.2%, about 2.3%, about 2.4% or about
2.5% by weight. In certain embodiments, the present invention relates to
any one of the above-mentioned compositions, wherein the benzyl alcohol
is present in about 1.4% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
the benzyl alcohol is present in about 1.5% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the benzyl alcohol is present in
about 2.1% by weight.

[0133]A composition comprising

[0134]water, from about 15% to about 40% by weight;

[0135]a co-surfactant, from about 10% to about 20% by weight;

[0136]an active agent, from about 0.01% to about 10% by weight;

[0137]a surfactant, from about 15% to about 40% by weight;

[0138]a propellant, from about 5% to about 15% by weight, wherein the
propellant is a hydrofluoroalkane;

[0139]a preservative, from about 0.005% to about 3.0% by weight; and

[0140]isopropyl myristate, from about 10% to about 35% by weight.

[0141]A composition consisting essentially of water, from about 15% to
about 40% by weight;

[0142]a co-surfactant, from about 10% to about 20% by weight;

[0143]an active agent, from about 0.01% to about 10% by weight;

[0144]a surfactant, from about 15% to about 40% by weight;

[0145]a propellant, from about 5% to about 15% by weight, wherein the
propellant is a hydrofluoroalkane;

[0146]a preservative, from about 0.005% to about 3.0% by weight; and

[0147]isopropyl myristate, from about 10% to about 35% by weight.

[0148]A composition consisting of water, from about 15% to about 40% by
weight;

[0149]a co-surfactant, from about 10% to about 20% by weight;

[0150]an active agent, from about 0.01% to about 10% by weight;

[0151]a surfactant, from about 15% to about 40% by weight;

[0152]a propellant, from about 5% to about 15% by weight, wherein the
propellant is a hydrofluoroalkane;

[0153]a preservative, from about 0.005% to about 3.0% by weight; and

[0154]isopropyl myristate, from about 10% to about 35% by weight.

[0155]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the composition does not
comprise ethanol.

[0156]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein water is present in a quantity
from about 17% to about 25% by weight. In certain embodiments, the
present invention relates to any one of the above-mentioned compositions,
wherein water is present in a quantity from about 18% to about 24% by
weight. In certain embodiments, the present invention relates to any one
of the above-mentioned compositions, wherein water is present in about
18%, about 19%, about 20%, about 21%, about 22%, about 23%, or about 24%
by weight. In certain embodiments, the present invention relates to any
one of the above-mentioned compositions, wherein water is present in
about 18% by weight. In certain embodiments, the present invention
relates to any one of the above-mentioned compositions, wherein water is
present in about 20% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
water is present in about 24% by weight.

[0157]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the co-surfactant is ethylene
glycol, propylene glycol, or glycerol.

[0158]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the co-surfactant is propylene
glycol.

[0159]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the co-surfactant is present in
a quantity from about 11% to about 18% by weight. In certain embodiments,
the present invention relates to any one of the above-mentioned
compositions, wherein the co-surfactant is present in a quantity from
about 12% to about 17% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
the co-surfactant is present in about 13%, about 14%, about 15%, or about
16% by weight. In certain embodiments, the present invention relates to
any one of the above-mentioned compositions, wherein the co-surfactant is
present in about 13% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
the co-surfactant is present in about 14% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the co-surfactant is present in
about 15% by weight. In certain embodiments, the present invention
relates to any one of the above-mentioned compositions, wherein the
co-surfactant is present in about 16% by weight.

[0160]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the active agent is selected
from the group consisting of an antibiotic agent, an anti-inflammatory
agent, an anesthetic, an antimicrobial agent, and a keratolytic agent.

[0161]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the active agent is present in
a quantity from about 0.05% to about 8.0% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the active agent is present in a
quantity from about 0.06% to about 7% by weight. In certain embodiments,
the present invention relates to any one of the above-mentioned
compositions, wherein the active agent is present in about 0.06%, about
0.07%, about 0.08%, about 0.1%, about 0.2%, about 0.3%, about 0.4%, about
0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1.0%, about
1.5%, about 2.0%, about 2.5%, about 3.0%, about 3.5%, about 4.0%, about
4.5%, about 5.0%, about 5.5%, about 6.0%, about 6.5%, or about 7.0% by
weight.

[0162]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the active agent is an
anesthetic.

[0163]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the anesthetic is lidocaine.

[0164]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the anesthetic is present in a
quantity from about 1% to about 6% by weight. In certain embodiments, the
present invention relates to any one of the above-mentioned compositions,
wherein the anesthetic is present in a quantity from about 2% to about 5%
by weight. In certain embodiments, the present invention relates to any
one of the above-mentioned compositions, wherein the anesthetic is
present in about 2.0%, about 2.5%, about 3.0%, about 3.5%, about 4.0%,
about 4.5%, or about 5.0% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
the anesthetic is present in about 3.5% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the anesthetic is present in about
4.0% by weight. In certain embodiments, the present invention relates to
any one of the above-mentioned compositions, wherein the anesthetic is
present in about 4.5% by weight.

[0165]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the active agent is an
anti-inflammatory agent.

[0166]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the anti-inflammatory agent is
a non-steroidal anti-inflammatory agent or a steroidal anti-inflammatory
agent.

[0167]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the steroidal anti-inflammatory
agent is triamcinolone acetonide or betamethasone dipropionate.

[0168]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the steroidal anti-inflammatory
agent is triamcinolone acetonide.

[0169]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the steroidal anti-inflammatory
agent is betamethasone dipropionate.

[0170]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the anti-inflammatory agent is
present in a quantity from about 0.05% to about 1.5% by weight. In
certain embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the anti-inflammatory agent is
present in a quantity from about 0.06% to about 1.0% by weight. In
certain embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the anti-inflammatory agent is
present in about 0.06%, about 0.07%, about 0.08%, about 0.09%, about
0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about
0.7%, about 0.8%, about 0.9%, or about 1.0% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the anti-inflammatory agent is
present in about 0.08% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
the anti-inflammatory agent is present in about 0.09% by weight. In
certain embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the anti-inflammatory agent is
present in about 0.1% by weight.

[0171]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the active agent is a
keratolytic agent.

[0172]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the keratolytic agent is
salicylic acid.

[0173]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the keratolytic agent is
present in a quantity from about 2.0% to about 8.0% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the keratolytic agent is present in
a quantity from about 3.0% to about 7.0% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the keratolytic agent is present in
about 3.0%, about 3.5%, about 4.0%, about 4.5%, about 5.0%, about 5.5%,
about 6.0%, about 6.5%, or about 7.0% by weight. In certain embodiments,
the present invention relates to any one of the above-mentioned
compositions, wherein the keratolytic agent is present in about 5.0% by
weight. In certain embodiments, the present invention relates to any one
of the above-mentioned compositions, wherein the keratolytic agent is
present in about 5.5% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
the keratolytic agent is present in about 6.0% by weight.

[0174]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the active agent is a
skin-soothing agent.

[0175]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the skin-soothing agent is aloe
vera.

[0176]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the skin-soothing agent is
present in a quantity from about 0.05% to about 2.0% by weight. In
certain embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the skin-soothing agent is present
in a quantity from about 0.08% to about 1.5% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the skin-soothing agent is present
in about 0.08%, about 0.09%, about 0.1%, about 0.2%, about 0.3%, about
0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about
1.0%, about 1.1%, about 1.2%, about 1.3%, about 1.4%, or about 1.5% by
weight. In certain embodiments, the present invention relates to any one
of the above-mentioned compositions, wherein the skin-soothing agent is
present in about 0.08% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
the skin-soothing agent is present in about 0.09% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the skin-soothing agent is present
in about 0.1% by weight.

[0177]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, further comprising a second active
agent.

[0179]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the surfactant is a
polysorbate.

[0180]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the surfactant is polysorbate
80.

[0181]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the surfactant is present in a
quantity from about 32% to about 39% by weight. In certain embodiments,
the present invention relates to any one of the above-mentioned
compositions, wherein the surfactant is present in a quantity from about
33% to about 39% by weight. In certain embodiments, the present invention
relates to any one of the above-mentioned compositions, wherein the
surfactant is present in about 33%, about 34%, about 35%, about 36%,
about 37%, about 38%, or about 39% by weight. In certain embodiments, the
present invention relates to any one of the above-mentioned compositions,
wherein the surfactant is present in about 34% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the surfactant is present in about
36% by weight. In certain embodiments, the present invention relates to
any one of the above-mentioned compositions, wherein the surfactant is
present in about 38% by weight.

[0182]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the hydrofluoroalkane is
1,1,1,2,3,3,3-heptafluoropropane, 1,1,1,2-tetrafluoroethane, or a mixture
thereof.

[0183]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the hydrofluoroalkane is
1,1,1,2-tetrafluoroethane.

[0184]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the propellant is present in a
quantity from about 5% to about 13% by weight. In certain embodiments,
the present invention relates to any one of the above-mentioned
compositions, wherein the propellant is present in a quantity from about
6% to about 13% by weight. In certain embodiments, the present invention
relates to any one of the above-mentioned compositions, wherein the
propellant is present in about 6%, about 7%, about 8%, about 9%, about
10%, about 11%, about 12%, or about 13% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the propellant is present in about
6% by weight. In certain embodiments, the present invention relates to
any one of the above-mentioned compositions, wherein the propellant is
present in about 12% by weight.

[0186]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the preservative is a
quaternary ammonium compound, an alcoholic agent, or a combination of
both.

[0187]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the preservative is
benzalkonium chloride.

[0188]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the preservative is benzyl
alcohol.

[0189]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the preservative is a
combination of benzalkonium chloride and benzyl alcohol.

[0190]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the preservative is present in
a quantity from about 0.005% to about 3% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the preservative is present in a
quantity from about 0.01% to about 2.5% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the preservative is present in
about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about
0.06%, about 0.07%, about 0.08%, about 1.0%, about 1.5%, about 2.0%, or
about 2.5% by weight.

[0191]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the benzalkonium chloride is
present in a quantity from about 0.008% to about 0.08% by weight. In
certain embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the benzalkonium chloride is
present in about 0.008%, about 0.009%, about 0.01%, about 0.02%, about
0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, or about 0.08%
by weight. In certain embodiments, the present invention relates to any
one of the above-mentioned compositions, wherein the benzalkonium
chloride is present in about 0.01% by weight. In certain embodiments, the
present invention relates to any one of the above-mentioned compositions,
wherein the benzalkonium chloride is present in about 0.02% by weight. In
certain embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the benzalkonium chloride is
present in about 0.04% by weight.

[0192]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the benzyl alcohol is present
in a quantity from about 0.8% to about 3.0% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the benzyl alcohol is present in a
quantity from about 1.2% to about 2.5% by weight. In certain embodiments,
the present invention relates to any one of the above-mentioned
compositions, wherein the benzyl alcohol is present in about 1.2%, about
1.3%, about 1.4%, about 1.5%, about 1.6%, about 1.7%, about 1.8%, about
1.9%, about 2.0%, about 2.1%, about 2.2%, about 2.3%, about 2.4% or about
2.5% by weight. In certain embodiments, the present invention relates to
any one of the above-mentioned compositions, wherein the benzyl alcohol
is present in about 1.4% by weight. In certain embodiments, the present
invention relates to any one of the above-mentioned compositions, wherein
the benzyl alcohol is present in about 1.5% by weight. In certain
embodiments, the present invention relates to any one of the
above-mentioned compositions, wherein the benzyl alcohol is present in
about 2.1% by weight.

[0193]In certain embodiments, the invention relates to a composition
comprising

[0194]water, in about 20% by weight;

[0195]a co-surfactant, in about 14% by weight, wherein the co-surfactant
is propylene glycol;

[0196]an active agent, in about 4.0% by weight, wherein the active agent
is lidocaine;

[0197]a surfactant, in about 39% by weight, wherein the surfactant is
polysorbate 80;

[0198]a propellant, in about 6% by weight, wherein the propellant is
1,1,1,2-tetrafluoroethane;

[0199]a preservative, wherein the preservative is benzalkonium chloride,
in about 0.04% by weight, and benzyl alcohol, in about 1.9% by weight;
and

[0200]isopropyl myristate, in about 15% by weight.

[0201]In certain embodiments, the invention relates to a composition
consisting essentially of water, in about 20% by weight;

[0202]a co-surfactant, in about 14% by weight, wherein the co-surfactant
is propylene glycol;

[0203]an active agent, in about 4.0% by weight, wherein the active agent
is lidocaine;

[0204]a surfactant, in about 39% by weight, wherein the surfactant is
polysorbate 80;

[0205]a propellant, in about 6% by weight, wherein the propellant is
1,1,1,2-tetrafluoroethane;

[0206]a preservative, wherein the preservative is benzalkonium chloride,
in about 0.04% by weight, and benzyl alcohol, in about 1.9% by weight;
and

[0207]isopropyl myristate, in about 15% by weight.

[0208]In certain embodiments, the invention relates to a composition
consisting of water, in about 20% by weight;

[0209]a co-surfactant, in about 14% by weight, wherein the co-surfactant
is propylene glycol;

[0210]an active agent, in about 4.0% by weight, wherein the active agent
is lidocaine;

[0211]a surfactant, in about 39% by weight, wherein the surfactant is
polysorbate 80;

[0212]a propellant, in about 6% by weight, wherein the propellant is
1,1,1,2-tetrafluoroethane;

[0213]a preservative, wherein the preservative is benzalkonium chloride,
in about 0.04% by weight, and benzyl alcohol, in about 1.9% by weight;
and

[0217]a co-surfactant, in about 13% by weight, wherein the co-surfactant
is propylene glycol;

[0218]an active agent, in about 5% by weight, wherein the active agent is
salicylic acid;

[0219]a surfactant, in about 36% by weight, wherein the surfactant is
polysorbate 80;

[0220]a propellant, in about 12% by weight, wherein the propellant is
1,1,1,2-tetrafluoroethane;

[0221]isopropyl myristate, in about 14% by weight; and

[0222]a second active agent, in about 0.09% by weight, wherein the second
active agent is aloe vera.

[0223]In certain embodiments, the present invention relates to a
composition consisting essentially of

[0224]water, in about 19% by weight;

[0225]a co-surfactant, in about 13% by weight, wherein the co-surfactant
is propylene glycol;

[0226]an active agent, in about 5% by weight, wherein the active agent is
salicylic acid;

[0227]a surfactant, in about 36% by weight, wherein the surfactant is
polysorbate 80;

[0228]a propellant, in about 12% by weight, wherein the propellant is
1,1,1,2-tetrafluoroethane;

[0229]isopropyl myristate, in about 14% by weight; and

[0230]a second active agent, in about 0.09% by weight, wherein the second
active agent is aloe vera.

[0231]In certain embodiments, the present invention relates to a
composition consisting of

[0232]water, in about 19% by weight;

[0233]a co-surfactant, in about 13% by weight, wherein the co-surfactant
is propylene glycol;

[0234]an active agent, in about 5% by weight, wherein the active agent is
salicylic acid;

[0235]a surfactant, in about 36% by weight, wherein the surfactant is
polysorbate 80;

[0236]a propellant, in about 12% by weight, wherein the propellant is
1,1,1,2-tetrafluoroethane;

[0237]isopropyl myristate, in about 14% by weight; and

[0238]a second active agent, in about 0.09% by weight, wherein the second
active agent is aloe vera.

[0239]In certain embodiments, the present invention relates to a
composition comprising water, in about 20% by weight;

[0240]a co-surfactant, in about 14% by weight, wherein the co-surfactant
is propylene glycol;

[0241]an active agent, in about 0.09% by weight, wherein the active agent
is triamcinolone acetonide;

[0242]a surfactant, in about 38% by weight, wherein the surfactant is
polysorbate 80;

[0243]a propellant, in about 12% by weight, wherein the propellant is
1,1,1,2-tetrafluoroethane; and

[0244]isopropyl myristate, in about 15% by weight.

[0245]In certain embodiments, the present invention relates to a
composition consisting essentially of water, in about 20% by weight;

[0246]a co-surfactant, in about 14% by weight, wherein the co-surfactant
is propylene glycol;

[0247]an active agent, in about 0.09% by weight, wherein the active agent
is triamcinolone acetonide;

[0248]a surfactant, in about 38% by weight, wherein the surfactant is
polysorbate 80;

[0249]a propellant, in about 12% by weight, wherein the propellant is
1,1,1,2-tetrafluoroethane; and

[0250]isopropyl myristate, in about 15% by weight.

[0251]In certain embodiments, the present invention relates to a
composition consisting of

[0252]water, in about 20% by weight;

[0253]a co-surfactant, in about 14% by weight, wherein the co-surfactant
is propylene glycol;

[0254]an active agent, in about 0.09% by weight, wherein the active agent
is triamcinolone acetonide;

[0255]a surfactant, in about 38% by weight, wherein the surfactant is
polysorbate 80;

[0256]a propellant, in about 12% by weight, wherein the propellant is
1,1,1,2-tetrafluoroethane; and

[0257]isopropyl myristate, in about 15% by weight.

[0258]In certain embodiments, the present invention relates to a
composition comprising water, in about 20% by weight;

[0259]a co-surfactant, in about 14% by weight, wherein the co-surfactant
is propylene glycol;

[0260]an active agent, in about 0.09% by weight, wherein the active agent
is betamethasone dipropionate;

[0261]a surfactant, in about 38% by weight, wherein the surfactant is
polysorbate 80;

[0262]a propellant, in about 12% by weight, wherein the propellant is
1,1,1,2-tetrafluoroethane; and

[0263]isopropyl myristate, in about 15% by weight.

[0264]In certain embodiments, the present invention relates to a
composition consisting essentially of

[0265]water, in about 20% by weight;

[0266]a co-surfactant, in about 14% by weight, wherein the co-surfactant
is propylene glycol;

[0267]an active agent, in about 0.09% by weight, wherein the active agent
is betamethasone dipropionate;

[0268]a surfactant, in about 38% by weight, wherein the surfactant is
polysorbate 80;

[0269]a propellant, in about 12% by weight, wherein the propellant is
1,1,1,2-tetrafluoroethane; and

[0270]isopropyl myristate, in about 15% by weight.

[0271]In certain embodiments, the present invention relates to a
composition consisting of

[0272]water, in about 20% by weight;

[0273]a co-surfactant, in about 14% by weight, wherein the co-surfactant
is propylene glycol;

[0274]an active agent, in about 0.09% by weight, wherein the active agent
is betamethasone dipropionate;

[0275]a surfactant, in about 38% by weight, wherein the surfactant is
polysorbate 80;

[0276]a propellant, in about 12% by weight, wherein the propellant is
1,1,1,2-tetrafluoroethane; and

[0277]isopropyl myristate, in about 15% by weight.

[0278]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions, wherein the composition is in an
aerosol container.

[0279]In certain embodiments, the present invention relates to any one of
the above-mentioned compositions in the form of a foam. In certain
embodiments, the foam is produced by actuation of an aerosol container
comprising the composition.

Exemplary Methods of Formulation

[0280]In certain embodiments, the present invention relates to a method of
making a composition, comprising the steps of

[0281]mixing water and a co-surfactant, thereby forming a first solution;

[0282]optionally heating the first solution;

[0283]adding an active agent to the first solution and mixing, thereby
forming a second solution;

[0284]adding a component of an oil phase to the second solution and
mixing, thereby forming a two-phase mixture;

[0285]adding a surfactant to the two-phase mixture and mixing; thereby
forming a microemulsion;

[0286]adding the microemulsion to an aerosol container; and

[0287]pressurizing the aerosol container with a propellant, wherein the
propellant is a hydrofluoroalkane.

[0288]In certain embodiments, the present invention relates to any one of
the above-mentioned methods, wherein the component of the oil phase is
selected from the group consisting of mineral oil, emollient oils,
saturated fatty acids, unsaturated fatty acids, medium chain-length
triglycerides, isopropyl myristate, isopropyl palmitate, oleic acid,
isostearylic isostearate, triacetin, ethyl oleate, and octyl octanoate.
In certain embodiments, the present invention relates to any one of the
above-mentioned methods, wherein the component of the oil phase is
isopropyl myristate.

[0289]In certain embodiments, the present invention relates to a method of
making a composition, comprising the steps of

[0290]mixing water and a co-surfactant, thereby forming a first solution;

[0291]optionally heating the first solution;

[0292]adding an active agent to the first solution and mixing, thereby
forming a second solution;

[0293]adding isopropyl myristate to the second solution and mixing,
thereby forming a two-phase mixture;

[0294]adding a surfactant to the two-phase mixture and mixing; thereby
forming a micro emulsion;

[0295]adding the microemulsion to an aerosol container; and

[0296]pressurizing the aerosol container with a propellant, wherein the
propellant is a hydrofluoroalkane.

[0297]In certain embodiments, the present invention relates to a method of
making a composition, comprising the steps of

[0298]mixing water and a co-surfactant, thereby forming a first solution;

[0299]adding a component of an oil phase to the first solution and mixing,
thereby forming a two-phase mixture;

[0300]adding a surfactant to the two-phase mixture and mixing; thereby
forming a microemulsion base;

[0301]optionally heating the microemulsion base;

[0302]adding an active agent to the microemulsion base and mixing, thereby
forming an active agent-containing microemulsion;

[0303]adding the active agent-containing microemulsion to an aerosol
container; and

[0304]pressurizing the aerosol container with a propellant, wherein the
propellant is a hydrofluoroalkane.

[0305]In certain embodiments, the present invention relates to any one of
the above-mentioned methods, wherein the component of the oil phase is
selected from the group consisting of mineral oil, emollient oils,
saturated fatty acids, unsaturated fatty acids, medium chain-length
triglycerides, isopropyl myristate, isopropyl palmitate, oleic acid,
isostearylic isostearate, triacetin, ethyl oleate, and octyl octanoate.
In certain embodiments, the present invention relates to any one of the
above-mentioned methods, wherein the component of the oil phase is
isopropyl myristate.

[0306]In certain embodiments, the present invention relates to a method of
making a composition, comprising the steps of

[0307]mixing water and a co-surfactant, thereby forming a first solution;

[0308]adding isopropyl myristate to the first solution and mixing, thereby
forming a two-phase mixture;

[0309]adding a surfactant to the two-phase mixture and mixing; thereby
forming a microemulsion base;

[0310]optionally heating the microemulsion base;

[0311]adding an active agent to the microemulsion base and mixing, thereby
forming an active agent-containing microemulsion;

[0312]adding the active agent-containing microemulsion to an aerosol
container; and

[0313]pressurizing the aerosol container with a propellant, wherein the
propellant is a hydrofluoroalkane.

Exemplary Methods of Use

[0314]In certain embodiments, the present invention relates to a method of
treating the skin of a subject, comprising the step of

[0315]applying to the skin of a subject in need thereof any one of the
above-mentioned compositions.

[0316]In certain embodiments, the present invention relates to any one of
the above-mentioned methods, wherein the subject is suffering from a
dermatological condition. In certain embodiments, the present invention
relates to any one of the above-mentioned methods, wherein the subject is
suffering from a dermatological condition selected from the group
consisting of a bacterial infection, a viral infection, a fungal
infection, inflammation, dandruff, cradle cap, warts, seborrheic
dermatitis, pain, and acne. In certain embodiments, the present invention
relates to any one of the above-mentioned methods, wherein the skin of
the subject is to be anesthetized. In certain embodiments, the present
invention relates to any one of the above-mentioned methods, wherein the
skin of the subject is to be softened. In certain embodiments, the
present invention relates to any one of the above-mentioned methods,
wherein the skin of the subject is to be shed.

EXEMPLIFICATION

[0317]The invention now being generally described, it will be more readily
understood by reference to the following examples which are included
merely for purposes of illustration of certain aspects and embodiments of
the present invention, and are not intended to limit the invention.

[0318]In the Examples given below, model compounds were used as active
agents. It is understood, however, that any one or more of numerous
compounds can be incorporated into foamable stable microemulsion
compositions for topical administration using methods and techniques
described herein.

[0319]An oil-in-water microemulsion was formed spontaneously when
aqueous/co-surfactant, oil, and surfactant phases were mixed together in
appropriate concentrations. The formed microemulsion was clear, optically
isotropic and thermodynamically stable. The microemulsion was placed in
an aerosol container and charged with 1,1,1,2-tetrafluoroethane (HFA
134a) propellant resulting in thermodynamically-stable, clear composition
that dispensed as foam upon actuation.

[0320]The following manufacturing procedure was followed for preparation
of various microemulsion concentrates and foamable microemulsion
compositions: required quantities of DI water and ethyl alcohol (or
glycol when ethanol-free compositions were made) were mixed in a
container. Isopropyl Myristate was slowly added to the aqueous phase
forming two-phase system. Then, polysorbate 80 was slowly added to
two-phase system while mixing with prop mixer. Mixing was continued until
a clear solution was formed. To this microemulsion, 4% lidocaine was
added and mixed with prop mixer until all drug was completely dissolved.
Finally, 0.04% benzalkonium chloride was added as a preservative. The
obtained drug-containing microemulsion concentrate was filled into a
glass aerosol container and charged with HFA 134a in the range 6 to 12%
(w/w). The single phase was formed and no phase separation was observed
during the stability study at both, room temperature and 40° C.

[0323]Due to potential flammability hazard issues with ethyl alcohol at
large scales and undesirable ethanol skin-drying properties, oil-in-water
microemulsion was formulated without ethyl alcohol. Propylene glycol,
glycerin and ethylene glycol were examined as ethyl alcohol replacements.
Despite the fact that Hsiu-O et al. suggest that short chain alcohols
(i.e., ethyl alcohol) are required as co-surfactants for producing
microemulsions, we were able to formulate stable microemulsion
concentrates and foamable microemulsion compositions without ethyl
alcohol. Microemulsion concentrate #2 was charged with HFA 134a, and a
single-phase system was formed that upon actuation produced foam. HFA
134a level was 6% (w/w).

[0325]Using ethanol as a co-surfactant, a ternary phase diagram was
identified showing the combinations of water, oil and
surfactant/co-surfactant under which a clear microemulsion system can be
formulated. FIG. 1 shows the phase diagram of microemulsion systems
indicating the emulsion/microemulsion phase boundary at various
concentrations of water, isopropyl myristate (IPM), and polysorbate
80:ethanol (2:1). Polysorbate 80 is also referred to as "Tween® 80"
or "Tween 80" and vice versa. The concentrations of each constituent of
the microemulsions are depicted in the following table.

[0326]FIG. 2 shows the phase diagram of microemulsion systems indicating
the emulsion/microemulsion phase boundary at various concentrations of
water, isopropyl myristate (IPM), and polysorbate 80:propylene glycol
(2.5:1). The concentrations of each constituent of the microemulsions are
depicted in the following table.

[0328]DI water and propylene glycol were placed into a glass beaker.
Mixing was started. The mixture was heated to 65-70° C. Salicylic
acid was added and mixing was continued. Once a clear solution was
observed, aloe vera was added. Upon dissolution of aloe vera, isopropyl
myristate was added, with mixing. A two-phase system was observed.
Finally, polysorbate 80 was added to the two-phase system, while mixing.
A clear microemulsion was obtained.

[0329]The clear microemulsion (50 g) was filled into a glass aerosol
container. The container was crimped and pressurized with 7 g of HFA
134a. A clear, homogenous formulation was obtained (FIG. 3). Upon
actuation of the aerosol container, foam was produced (FIG. 4).

[0331]DI water and propylene glycol were placed into a glass beaker.
Mixing was started. The mixture was heated to 65-70° C.
Triamcinolone acetonide was added and mixing was continued. Once a clear
solution was observed, isopropyl myristate was added, with mixing. A
two-phase system was observed. Finally, polysorbate 80 was added to the
two-phase system, while mixing. A clear microemulsion was obtained. The
final weight may be adjusted with DI water, if necessary.

[0332]The clear microemulsion (50 g) was filled into a glass aerosol
container. The container was crimped and pressurized with 7 g of HFA
134a. A clear, homogenous formulation was obtained (FIG. 5). Upon
actuation of the aerosol container, foam was produced (FIG. 6).

[0334]DI water and propylene glycol were placed into a glass beaker.
Mixing was started. Isopropyl myristate was added and mixing was
continued. A two-phase system was observed. Polysorbate 80 was added to
the two-phase system, while mixing. The resultant mixture was then heated
to 50° C. Betamethasone dipropionate was added and mixing was
continued. A clear microemulsion was obtained.

[0335]The clear microemulsion (50 g) was filled into a glass aerosol
container. The container was crimped and pressurized with 7 g of HFA
134a. A clear, homogenous formulation was obtained (FIG. 7). Upon
actuation of the aerosol container, foam was produced (FIG. 8).

[0339]All of the U.S. patents and U.S. published patent applications cited
herein are hereby incorporated by reference.

EQUIVALENTS

[0340]Those skilled in the art will recognize, or be able to ascertain
using no more than routine experimentation, many equivalents to the
specific embodiments of the invention described herein. Such equivalents
are intended to be encompassed by the following claims.